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Fda Scientist Jobs in Indiana (NOW HIRING)

Manpower

IRL Senior Laboratory Scientist

Indianapolis, IN

$32.15/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Ensure compliance with FDA, AABB, CLIA, CAP, OSHA, and cGMP requirements What We're Looking For * A current, up-to-date resume * Bachelor's degree in Clinical Laboratory Science, Medical Technology ...

Elanco

Sr Research Scientist

Indianapolis, IN · Hybrid

$94K - $120K/yr

  • Retirement

  • PTO

... g., FDA/CVM, EMA) on analytical topics. What will give you a competitive edge (preferred ... Proven scientific leadership skills combined with strong problem-solving and creative thinking ...

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Fda Scientist information

See Indiana salary details

$48.1K

$106K

$130.8K

How much do fda scientist jobs pay per year?

As of Aug 12, 2026, the average yearly pay for fda scientist in Indiana is $105,950.00, according to ZipRecruiter salary data. Most workers in this role earn between $89,900.00 and $130,400.00 per year, depending on experience, location, and employer.

What is an FDA Scientist?

An FDA Scientist is a researcher or regulatory expert responsible for evaluating the safety, efficacy, and quality of pharmaceutical drugs, medical devices, biologics, and food products. They conduct laboratory research, review clinical trial data, and assess regulatory submissions to ensure compliance with federal laws and guidelines. FDA Scientists play a critical role in protecting public health by making science-based decisions on product approvals and safety standards.

What types of projects and responsibilities can I expect as an FDA Scientist?

As an FDA Scientist, you'll typically be involved in reviewing data from clinical trials, conducting laboratory research, evaluating the safety and efficacy of pharmaceuticals or medical devices, and preparing reports for regulatory submissions. You'll collaborate closely with multidisciplinary teams including chemists, statisticians, and regulatory specialists to ensure scientific rigor and adherence to federal standards. Some days may involve detailed data analysis, while others could require participating in cross-team meetings or interacting with external stakeholders. This dynamic environment offers opportunities to contribute to important public health decisions and develop specialized expertise over time.

How much do FDA scientists make?

FDA scientists typically earn between $70,000 and $130,000 annually, depending on experience, education, and location. Entry-level positions often start around $70,000, while experienced scientists with advanced degrees can earn over $120,000. Salaries may also include benefits such as health insurance and retirement plans.

What are the key skills and qualifications needed to thrive in the FDA Scientist position, and why are they important?

To thrive as an FDA Scientist, you need a solid background in biology, chemistry, pharmacology, or a related scientific field, typically supported by at least a bachelor's or advanced degree. Familiarity with regulatory submission systems, laboratory information management systems (LIMS), and relevant certifications such as Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) is important. Strong analytical thinking, attention to detail, and effective communication skills help you excel when collaborating with colleagues and presenting findings. These abilities ensure accurate data review and regulatory compliance, which are crucial for advancing public health and safety.

Does the FDA employ scientists?

Yes, the FDA employs scientists in various roles such as biologists, chemists, and pharmacologists to evaluate the safety and effectiveness of medical products, foods, and cosmetics. These scientists often work in laboratories, conduct research, and analyze data to support regulatory decisions, typically requiring relevant degrees and certifications. Their work is essential to ensuring public health and safety standards are met.
What are the most commonly searched types of Fda Scientist jobs in Indiana? The most popular types of Fda Scientist jobs in Indiana are:
What are popular job titles related to Fda Scientist jobs in Indiana? For Fda Scientist jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Fda Scientist jobs in Indiana look for? The top searched job categories for Fda Scientist jobs in Indiana are:
Fda Scientist jobs near you
Infographic showing various Fda Scientist job openings in Indiana as of August 2026, with employment types broken down into 80% Full Time, 15% Part Time, 4% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $105,950 per year, or $50.9 per hour.

Senior Scientist, Quality CMC

Aquestive Therapeutics

Portage, IN • On-site

Full-time

Re-posted 13 days ago

Job description

Job Summary:
The Senior Scientist, CMC Quality, bridges analytical science and product performance, providing scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks. This role drives complex investigations, informs quality-critical decisions, and partners cross-functionally to ensure sound, risk-based outcomes throughout the product lifecycle.
Responsibilities:
  • Serve as QC's primary interface to AR&D and Engineering, connecting analytical findings to process variability, formulation behavior, manufacturing deviations.
  • Support PQR/APQR product quality narratives, stability trend interpretation.
  • Lead and provide scientific oversight for complex OOS, OOT, deviation, and product quality investigations, determining whether observations arise from analytical, sampling, product, or manufacturing-related factors.
  • Lead the development and review of technically complex investigations, risk assessments, scientific rationales, and regulatory support documentation.
  • Provide independent, evidence-based scientific recommendations to support Quality decision-making and governance.
  • Understand method capability vs. product behavior.
  • Identify when method limitations drive variability, specifications may not reflect true capability, escalating systemic or recurring issues (i.e., lifecycle management).
  • Lead or support analytical and CMC quality improvement projects, as assigned.
  • Provide scientific assessment of stability trends, out of trend (OOT results), and potential impact to product quality.
  • Partner with Quality, AR&D and Regulatory to support IND/NDA/MAA submissions, post-approval commitments and annual updates.
  • Develop hypothesis-driven investigation strategies grounded in product behavior or formulation/process knowledge.
  • Drive root cause analysis and scientifically sound CAPAs.
  • Mentor junior scientists and provide technical guidance during investigations and problem-solving activities.

Qualifications:
  • BS in Chemistry, Pharmaceutical Sciences, or related field required.
  • Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls (CMC), or Analytical Sciences
  • Demonstrated ownership of complex OOS, OOT, and deviation investigations, including: developing investigation strategies, performing root cause analysis, defending conclusions and CAPAs
  • Significant experience in: Cross-functional investigations involving QC, Manufacturing, QA, and AR&D
  • Significant experience in interpreting analytical data in the context of product quality and process performance
  • Significant experience in stability programs, trend analysis, and product performance evaluation
  • Significant experience in analytical method capability, variability, and limitations
  • Strong understanding of: CMC development and commercialization, GMP and global regulatory expectations (FDA, EMA, ICH), OOS/OOT investigation frameworks and industry best practices
  • Demonstrated ability to: influence cross-functional teams without authority, articulate and defend scientific positions in QA and leadership forums
  • Strong business and product acumen, with understanding of: impact of quality decisions on supply, regulatory risk, and product lifecycle
  • Experience supporting regulatory submissions (IND/NDA/MAA), inspections, or audits preferred
  • Experience with instrumental techniques such as GC, HPLC, Dissolution.
  • Some travel required

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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